Methods and devices for renal nerve blocking

Abstract

A method and apparatus for treatment of cardiac and renal diseases associated with the elevated sympathetic renal nerve activity by implanting a device to block the renal nerve signals to and from the kidney. The device can be a drug pump or a drug eluding implant for targeted delivery of a nerve-blocking agent to the periarterial space of the renal artery.

1 - 23 . (canceled) 
     
     
         24 . An implantable system for treating a patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, renal disease, or chronic renal failure, the system comprising:
 a drug delivery device having a proximal section and a distal section, wherein the distal section is configured to be at least partially implanted within a periarterial space of the patient;   an implantable drug pump operatively connected to the proximal section of the drug delivery device, wherein the implantable drug pump further includes a drug reservoir; and   a controller configured to operate instructions that cause the implantable drug pump to deliver via the drug delivery device a neuromodulatory agent to a nerve that innervates a kidney of the patient in an amount and for a duration sufficient to modulate at least one of urine production, blood pressure, fluid retention, renin secretion, renal blood flow, waste excretion, and sodium retention in the patient.   
     
     
         25 . The implantable system of  claim 24  wherein a nerve that innervates a kidney of the patient comprises an afferent nerve. 
     
     
         26 . The implantable system of  claim 24  wherein a nerve that innervates a kidney of the patient comprises an efferent nerve. 
     
     
         27 . The implantable system of  claim 24  wherein the drug delivery device comprises a catheter. 
     
     
         28 . The implantable system of  claim 27  wherein the catheter is configured for insertion into the patient such that the distal portion of the catheter at least partially encircles a renal blood vessel. 
     
     
         29 . The implantable system of  claim 28  wherein the distal portion of the catheter comprises a coil section. 
     
     
         30 . The implantable system of  claim 27  wherein the distal portion of the catheter comprises a flexible section. 
     
     
         31 . The implantable system of  claim 27  wherein the distal portion of the catheter further comprises a porous section. 
     
     
         32 . The implantable system of  claim 31  wherein the porous section is configured to receive an in-growth of tissue. 
     
     
         33 . The implantable system of  claim 31  wherein the porous section is configured to prevent an in-growth of tissue. 
     
     
         34 . The implantable system of  claim 31  wherein the porous section comprises pores with a dimension from approximately 1.0 μm to approximately 20.0 μm. 
     
     
         35 . The implantable system of  claim 31  wherein the porous section further comprises a large pore section having a first pore size and a small pore section having a second pore size less than the first pore size. 
     
     
         36 . The implantable system of  claim 35  wherein the first pore size is configured for receiving tissue in-growth and the second pore size is configured to prevent tissue in-growth. 
     
     
         37 . The implantable system of  claim 35  wherein the small pore section is configured to deliver the neuromodulatory agent to the nerve of the patient. 
     
     
         38 . The implantable system of  claim 35  wherein the first pore size is approximately 20 μm and the second pore size is approximately 1 μm. 
     
     
         39 . The implantable system of  claim 31  wherein the porous section comprises PTFE. 
     
     
         40 . The implantable system of  claim 27  wherein the distal section of the catheter comprises means for facilitating tissue ingrowth. 
     
     
         41 . The implantable system of  claim 27  wherein the distal section of the catheter comprises means for directional delivery of the neuromodulatory agent. 
     
     
         42 . The implantable system of  claim 27  wherein the distal section of the catheter comprises a Dacron cuff. 
     
     
         43 . The implantable system of  claim 27  wherein the catheter comprises a plurality of branches. 
     
     
         44 . The implantable system of  claim 43  wherein the catheter comprises a bifurcated catheter. 
     
     
         45 . The implantable system of  claim 44  wherein the bifurcated catheter is configured for bilateral placement. 
     
     
         46 . The implantable system of  claim 43  wherein the plurality of branches comprise a plurality of holes for delivering the neuromodulatory agent to the nerve of the patient. 
     
     
         47 . The implantable system of  claim 27  wherein the distal portion of the catheter comprises an end hole for delivery of the neuromodulatory agent. 
     
     
         48 . The implantable system of  claim 27  wherein the catheter is configured with at least one side port for delivery of the neuromodulatory agent. 
     
     
         49 . The implantable system of  claim 27  wherein the distal portion of the catheter further comprises means for delivering the nerve-blocking agent to the nerve of the patient. 
     
     
         50 . The implantable system of  claim 24  wherein the neuromodulatory agent is at least one anesthetic, neurotoxin, alcohol, phenol, ketamine and antidepressant. 
     
     
         51 . The implantable system of  claim 24  wherein the neuromodulatory agent is an anesthetic. 
     
     
         52 . The implantable system of  claim 51  wherein the anesthetic is amino ester, amino amide and/or bupivacaine. 
     
     
         53 . The implantable system of  claim 24  wherein the drug delivery device is further configured to deliver a medicament for suppressing inflammation in the periarterial space of the patient. 
     
     
         54 . The implantable system of  claim 53  wherein the medicament for suppressing inflammation in the periarterial space of the patient is a steroid. 
     
     
         55 . The implantable system of  claim 24 , further comprising means for suppressing inflammation in the periarterial space of the patient. 
     
     
         56 . The implantable system of  claim 24  wherein the controller comprises a programmable microprocessor. 
     
     
         57 . The implantable system of  claim 56 , further comprising a remote communication link for programming the programmable microprocessor. 
     
     
         58 . The implantable system of  claim 24  wherein the drug reservoir comprises a septum. 
     
     
         59 . The implantable system of  claim 58  wherein the septum comprises self-sealing means. 
     
     
         60 . The implantable system of  claim 24  wherein the implantable drug pump further comprises a displacement mechanism for forcing the neuromodulatory agent from the drug reservoir to the drug delivery device. 
     
     
         61 . The implantable system of  claim 60  wherein the displacement mechanism comprises an elastic diaphragm. 
     
     
         62 . The implantable system of  claim 61  wherein the displacement mechanism further comprises a propellant. 
     
     
         63 . The implantable system of  claim 24  wherein the implantable drug pump further comprises means for displacing the neuromodulatory agent from the drug reservoir to the drug delivery device. 
     
     
         64 . The implantable system of  claim 24 , further comprising a rate limiting element for controlling the delivery rate of the neuromodulatory agent. 
     
     
         65 . The implantable system of  claim 24  wherein the distal section of the drug delivery device comprises an electrode. 
     
     
         66 . An apparatus for treating a patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, renal disease, or chronic renal failure, the apparatus comprising:
 an implantable catheter having a proximal section and a distal section, wherein the distal section is configured to be at least partially positioned within a periarterial space of the patient; and   a subcutaneous injection port operatively connected to the proximal section of the implantable catheter,   wherein the subcutaneous injection port is configured to receive an injection of a neuromodulatory agent and supply the neuromodulatory agent via the implantable catheter to a nerve that innervates a kidney of the patient in an amount and for a duration sufficient to modulate at least one of urine production, blood pressure, fluid retention, renin secretion, renal blood flow, waste excretion, and sodium retention in the patient.   
     
     
         67 . The apparatus of  claim 66  wherein a nerve that innervates a kidney of the patient further comprises an afferent nerve. 
     
     
         68 . The apparatus of  claim 66  wherein a nerve that innervates a kidney of the patent further comprises an efferent nerve. 
     
     
         69 . The apparatus of  claim 66 , further comprising an external drug pump operatively and detachably connected to the subcutaneous injection port. 
     
     
         70 . The apparatus of  claim 66  wherein the subcutaneous injection port is configured to receive an injection of a neuromodulatory agent from a needle. 
     
     
         71 . The apparatus of  claim 66  wherein the subcutaneous injection port is configured to receive an injection of a neuromodulatory agent from a gravity feed. 
     
     
         72 . The apparatus of  claim 66  wherein the subcutaneous injection port is configured to receive an injection of a neuromodulatory agent from an external pump. 
     
     
         73 . The apparatus of  claim 66  wherein the catheter is configured for insertion into the patient such that the distal portion of the catheter at least partially encircles a renal blood vessel. 
     
     
         74 . The apparatus of  claim 73  wherein the distal portion of the catheter comprises a coil section. 
     
     
         75 . The apparatus of  claim 66  wherein the distal portion of the catheter comprises a flexible section. 
     
     
         76 . The apparatus of  claim 66  wherein the distal portion of the catheter further comprises a porous section. 
     
     
         77 . The apparatus of  claim 76  wherein the porous section is configured to receive an in-growth of tissue. 
     
     
         78 . The apparatus of  claim 76  wherein the porous section is configured to prevent an in-growth of tissue. 
     
     
         79 . The apparatus of  claim 76  wherein the porous section comprises pores with a dimension from approximately 1.0 μm to approximately 20.0 μm. 
     
     
         80 . The apparatus of  claim 76  wherein the porous section comprises PTFE. 
     
     
         81 . The apparatus of  claim 76  wherein the porous section further comprises a large pore section having a first pore size and a small pore section having a second pore size less than the first pore size. 
     
     
         82 . The apparatus of  claim 81  wherein the first pore size is configured for receiving tissue in-growth and the second pore size is configured to prevent tissue in-growth. 
     
     
         83 . The apparatus of  claim 81  wherein the small pore section is configured to deliver the neuromodulatory agent to the nerve of the patient. 
     
     
         84 . The apparatus of  claim 81  wherein the first pore size is approximately 20 μm and the second pore size is approximately 1 μm. 
     
     
         85 . The apparatus of  claim 66  wherein the distal section of the catheter comprises means for facilitating tissue ingrowth. 
     
     
         86 . The apparatus of  claim 66  wherein the distal section of the catheter comprises means for directional delivery of the neuromodulatory agent. 
     
     
         87 . The apparatus of  claim 66  wherein the distal section of the catheter comprises a Dacron cuff. 
     
     
         88 . The apparatus of  claim 66  wherein the catheter comprises a plurality of branches. 
     
     
         89 . The apparatus of  claim 88  wherein the catheter comprises a bifurcated catheter. 
     
     
         90 . The apparatus of  claim 89  wherein the bifurcated catheter is configured for bilateral placement. 
     
     
         91 . The apparatus of  claim 88  wherein the plurality of branches comprise a plurality of holes for delivering the neuromodulatory agent to the nerve of the patient. 
     
     
         92 . The apparatus of  claim 69  wherein the distal portion of the catheter comprises an end hole for delivery of the neuromodulatory agent. 
     
     
         93 . The implantable system of  claim 69  wherein the catheter is configured with at least one side port for delivery of the neuromodulatory agent. 
     
     
         94 . An apparatus for treating a patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, renal disease, or chronic renal failure, the apparatus comprising:
 a drug delivery device configured to be at least partially positioned in a periarterial space of the patient;   an electrode configured to be positioned proximate to a nerve that innervates a kidney of the patient; and   an energy generator operatively coupled to at least one of the drug delivery device and the electrode.   
     
     
         95 . The apparatus of  claim 94  wherein the energy generator is operatively connected to the electrode and comprises a controller containing instructions configured to cause the electrode to deliver electrical signals to the nerve. 
     
     
         96 . The apparatus of  claim 94 , further comprising a controller containing instructions configured to cause the drug delivery device to inhibit neural activity along the nerve for a period of time sufficient to modulate at least one urine production, blood pressure, fluid retention, renin secretion, renal blood flow, waste excretion, and sodium retention in the patient. 
     
     
         97 . The apparatus of  claim 94  wherein the drug delivery device comprises a catheter configured for insertion in the patient such that a distal portion of the catheter extends within the periarterial space. 
     
     
         98 . The apparatus of  claim 97  wherein the distal portion of the catheter has a plurality of holes through which a nerve-blocking agent can be delivered to a renal nerve of the patient. 
     
     
         99 . The apparatus of  claim 97  wherein the distal portion of the catheter comprises a porous section having pores through which a nerve-blocking agent can be delivered to a renal nerve of the patient. 
     
     
         100 . The apparatus of  claim 99  wherein the porous section has pores with a dimension of from approximately 1.0 μm to 20.0 μm. 
     
     
         101 . The apparatus of  claim 99  wherein the porous section has a large pore section having a first pore size and a small pore section having a second pore size less than the first pore size. 
     
     
         102 . The apparatus of  claim 101  wherein the first pore size is configured for tissue in-growth and the second pore size is configured to prevent tissue in-growth. 
     
     
         103 . The apparatus of  claim 101  wherein the first pore size is approximately 20 μm and the second pore size is approximately 1 μm. 
     
     
         104 . The apparatus of  claim 97  wherein the electrode is coupled to the distal portion of the catheter. 
     
     
         105 . The apparatus of  claim 97  wherein the electrode comprises a first electrode configured to be located proximally of a nerve modulating site and a second electrode configured to be located distally of the nerve modulating site. 
     
     
         106 . The apparatus of  claim 105  wherein at least one of the first and second electrodes comprises a sensor that senses neural activity. 
     
     
         107 . The apparatus of  claim 105  wherein the first and second electrodes comprise contacts configured to apply stimulation to a renal nerve of the patient. 
     
     
         108 . The apparatus of  claim 97  wherein the distal portion of the catheter comprises a flexible section configured to at least partially wrap around a portion of a renal vessel of the patient. 
     
     
         109 . The apparatus of  claim 108  wherein the flexible section further comprises at least one of a coil, a plurality of openings and a porous section. 
     
     
         110 . The apparatus of  claim 94  wherein the drug delivery device comprise a drug-eluting implant. 
     
     
         111 . The apparatus of  claim 110  wherein the drug-eluting implant is configured to at least partially wrap around at least a portion of a renal vessel of the patient. 
     
     
         112 . The apparatus of  claim 94  wherein the drug delivery device comprises a sustained release, bio-degradable implant having a nerve-blocking agent. 
     
     
         113 . The apparatus of  claim 112  wherein the sustained release, bio-degradable implant comprises at least one of a patch, a plurality of micro-particles, a plurality of micro-spheres, and a plurality of micro-capsules. 
     
     
         114 . The apparatus of  claim 95  wherein the instructions are further configured to cause the controller to determine via the electrode whether neural activity along the renal nerve has been substantially blocked. 
     
     
         115 . The apparatus of  claim 96  wherein the energy generator is also operatively coupled to the electrode and the instructions are further configured to cause the controller to determine via the electrode whether neural activity along the nerve has been sufficiently altered. 
     
     
         116 . The apparatus of  claim 114  wherein the instructions are further configured to cause the drug delivery device to inhibit neural activity along the nerve based on whether neural activity along the renal nerve has been substantially blocked. 
     
     
         117 . The apparatus of  claim 114  wherein the instructions are further configured to cause the controller to electrically stimulate the renal nerve and cause a response in the patient. 
     
     
         118 . The apparatus of  claim 117  wherein the instructions are further configured to adjust the drug delivery based on the response caused in the patient. 
     
     
         119 . The apparatus of  claim 117  wherein an operator adjusts the drug delivery based on the response caused in the patient. 
     
     
         120 . An apparatus for at least partially blocking a renal nerve of a kidney of a human patient, the apparatus comprising:
 a drug eluting device configured for placement in a periarterial space of the patient,   wherein the drug eluting device is loaded with a diffusible supply of a nerve-blocking drug for delivery to the periarterial space in an amount and for a duration sufficient to modulate at least one of urine production, blood pressure, fluid retention, renin secretion, renal blood flow, waste excretion, and sodium retention in the patient.   
     
     
         121 . The apparatus of  claim 120  wherein the drug eluting device comprises a biodegradable polymeric matrix. 
     
     
         122 . The apparatus of  claim 120  where the nerve-blocking drug is selected from the group consisting of an anesthetic, alcohol, phenol, ketamine, neurotoxin, and antidepressant. 
     
     
         123 . The apparatus of  claim 120  wherein the drug eluting device comprises a biodegradable gel. 
     
     
         124 . The apparatus of  claim 120  wherein the drug eluting device comprises a drug-impregnated matrix. 
     
     
         125 . The apparatus of  claim 124  wherein the drug-impregnated matrix comprises a gel, patch, microspheres, suspension and/or solution. 
     
     
         126 . The apparatus of  claim 120  wherein the drug eluting device is configured to at least partially surround a renal blood vessel. 
     
     
         127 . The apparatus of  claim 120  wherein the drug eluting device comprises an osmotic pump. 
     
     
         128 . The apparatus of  claim 120  wherein the drug eluting device comprises a biodegradable compound. 
     
     
         129 . The apparatus of  claim 128  wherein the biodegradable compound is selected from the group consisting of a polyanhydride, polyester excipient, acid-glycolic acid copolymer and polycaprolactone. 
     
     
         130 . The apparatus of  claim 120  wherein the nerve-blocking drug is combined with a steroid. 
     
     
         131 . The apparatus of  claim 130  wherein the steroid comprises glucocorticoid. 
     
     
         132 . An apparatus for treating a patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, renal disease, or chronic renal failure, the apparatus comprising:
 a first drug delivery device configured to be positioned proximate to a first nerve that innervates a first kidney of the patient; and   a second drug delivery device configured to be positioned proximate to a second nerve that innervates a second kidney of the patient,   wherein the first drug delivery device is configured to deliver a nerve-blocking agent to the first nerve that innervates the first kidney and inhibit neural activity along the first nerve, and the second drug delivery device is configured to deliver the nerve-blocking agent to the second nerve that innervates the second kidney and inhibit neural activity along the second nerve, and wherein the nerve-blocking agent is delivered by the first and second drug delivery devices in an amount and for a period of time sufficient to modulate at least one urine production, blood pressure, fluid retention, renin secretion, renal blood flow, waste excretion, and sodium retention in the patient.   
     
     
         133 . The apparatus of  claim 132  wherein at least one of the first drug delivery device and the second drug delivery device is a drug eluting implant. 
     
     
         134 . The apparatus of  claim 132  wherein at least one of the first drug delivery device and the second drug delivery device is a catheter. 
     
     
         135 . The apparatus of  claim 132 , further comprising a drug reservoir operatively connected to the first drug delivery device and the second drug delivery device, and wherein the drug reservoir delivers the nerve-blocking agent to the first drug delivery device and the second drug delivery device. 
     
     
         136 . The apparatus of  claim 135  wherein the drug reservoir is configured to concurrently deliver the nerve-blocking agent to the first drug delivery device and the second drug delivery device. 
     
     
         137 . The apparatus of  claim 135  wherein the drug reservoir is configured to sequentially deliver the nerve-blocking agent to the first drug delivery device and the second drug delivery device. 
     
     
         138 . The apparatus of  claim 135  wherein the drug reservoir comprises an implantable drug pump. 
     
     
         139 . The apparatus of  claim 135  wherein the drug reservoir comprises an external drug reservoir.